The U.S. Food and Drug Administration (FDA) is providing this update to clarify expectations regarding filing entries of hand sanitizers. FDA has recently become aware that some entries of hand sanitizers have been disclaimed to the FDA, and the full message set was not filed for FDA review. Additionally, we are aware that some entries of hand sanitizers have been transmitted as cosmetics instead of drugs.
Hand sanitizers are drugs regulated by the FDA and are generally considered as over-the-counter (OTC) drug products. Hand sanitizers (and other drugs) imported into the United States must comply with all the applicable requirements under the Federal Food, Drug, and Cosmetic Act and the pertinent regulations found in Title 21 of the Code of Federal Regulations (21 CFR). As such, entries of hand sanitizers are required to be filed with the FDA upon importation with the appropriate PG Message set data for OTC drug products. Importers/entry filers should not disclaim entries of hand sanitizers.
Regarding the COVID-19 public health emergency, the FDA’s Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) and Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) do not affect the requirement to file entries of hand sanitizers with the FDA, or the product-specific requirements verified by FDA at the time of entry.
As described in the temporary policies, foreign manufacturers whose drugs, including over-the-counter drugs, are imported into the United States are required to register with FDA and submit a listing of drugs in commercial distribution, before the drugs are imported (as required by section 510 of the FD&C Act and 21 CFR Part 207). For more information on the drug importation process, please see:https://www.fda.gov/industry/regulated-products/human-drugs.
Tips to Help Entry Submission:
The FDA product code is determined according to the hand sanitizer’s active ingredient. For example:
|Active Ingredient in OTC Hand Sanitizer||FDA Product Code|
ACE requirements for the electronic transmission of drug products to FDA can be found in the FDA Supplemental Guide beginning on page 79. OTC drug products are transmitted using PG-01 Government Agency Program Code “DRU” and PG-01 Government Agency Processing Code “OTC”.
FDA is issuing this message as part of its continued outreach efforts to assist the import community; please make this information available to importers of record, consignees, manufacturers, shippers and other stakeholders.
Any questions or concerns regarding this message should be addressed to FDAImportsInquiry@fda.hhs.gov.